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Although it was encouraging when Brazil implemented new laws in the mid-1990s that expanded the scope of patentability to include pharmaceutical and biotechnology inventions, the Brazilian Patent Office (INPI) has not been able to accommodate the dramatic influx of patent applications that followed. At present, a serious backlog in patent prosecution delays the examination of applications by an average of 10 years, weakening the intellectual property infrastructure in Brazil. In an attempt to address the backlog and expedite patent prosecution, several pilot programs have been introduced. These programs include the Green Patent pilot program, the implementation of Rules #151/2015 and #80/2013 and the Patent Prosecution Highway (PPH) pilot program.

Green Patent Pilot Program

The goal of this program, coined the “green” patent program, is to examine applications related to alternative energy, transportation, energy conservation, waste management, and agriculture (other qualifying technologies are listed here), in two years or less. Launched in 2012, Brazil was the first country to implement such a program. The program is currently in its 4th phase and is accepting applications filed under the Patent Cooperation Treaty (PCT).

In order to participate in the program, an applicant must submit an application that contains no more than 15 total claims (of which three are independent), and has not previously undergone technical examination. A submission of the form specific to the pilot program must be completed, and examination and publication must be requested. According to the INPI, the progress of applications in the program can be tracked online. However a limited period of time remains to participate in the Green Patent pilot program.

INPI Rule #151/2015

Rule #151/2015 of November 10, 2015, revised the conditions for requesting priority examination of a patent application. Specifically, Rule #151/2015 allows expedited patent prosecution for elderly (above 60 years of age) or ill applicants, or applicants that can show a third party is reproducing the subject matter of their patent application. Rule #151/2015 revoked the specific provision which allowed the Ministry of Health to request prioritized examination of applications involving drugs regularly purchased by the Brazilian Public Health System. However the Ministry of Health can still request priority examination of strategic drugs for the Public Health System pursuant to Rule #80/2013 (discussed below), and the Brazilian government has retained the right to prioritize the examination of applications relevant to national emergency or public interest.

For more information, an English translation of Rule #154/2015, which implements the PPH pilot program, is available: Rule154.

INPI Rule #80/2013

Rule #80/2013 of April 9, 2013, establishes the possibility of expedited examination of applications relating to the diagnosis, prophylaxis and treatment of Acquired Immunodeficiency Syndrome (AIDS), cancer or other neglected diseases. Neglected diseases include:

Chagas Disease;

Dengue / Dengue hemorrhagic fever;

Schistosomiasis;

Leprosy;

Leishmaniasis;

Malaria;

Tuberculosis;

Buruli ulcer;

Neurocysticercosis;

Echinococcosis;

Bouba;

Fascioliasis;

Paragonimiasis;

Filariasis;

Rabies;

Helminthiasis;

Manifestations from intoxications or poisonings due to poisonous and venomous animals.

There is no limitation on the use of Rule #80/2013 and any applications expedited become the responsibility of the Board of Patent – DIRPA. Determination of whether or not an application would qualify for expedited examination under Rule #80/2013 and whether or not there would be any disadvantage associated with requesting such expedited examination must be done on a case-by-case basis. Interestingly, since 2013, Rule #80/2013 has only been used 28 times.

Judicially Induced Fast-Track Examination of Patent Applications

In addition, applicants can request the Federal Courts issue an order imposing a “judicially induced fast-track” examination of a pending application. Specifically, during the last few years, several applicants have filed lawsuits in the Federal Courts requesting expedited examination of a patent application. Several applicants have been successful in obtaining injunctive relief with the Courts ordering INPI to complete examination of a pending application within 60 days. The 60 day period to conclude examination takes into consideration sections 48 and 49 of Statute #9,784/99, which provides general rules governing federal proceedings. The attached graphicsummarizes the decisions issued by each of the four intellectual property (IP) specialized courts as well as by the appellate courts. Both the 1st and 2nd Panels from the Court of Appeals for the 2nd Federal District, which are in charge of hearing appeals against decisions from the four IP specialized courts, have affirmed the decisions from the lower courts ordering INPI to expedite examination of pending applications.

Patent Prosecution Highway (PPH) Pilot Program

Implemented on January 11, 2016, the PPH pilot program is an agreement that exists between the United States Patent and Trademark Office (USPTO) and the INPI. Limited to oil and gas inventions (e.g. extraction, refining, and transportation) filed after January 1, 2013, the PPH allows expedited examination of a Brazilian application for which a corresponding U.S. application has received a Notice of Allowance from the USPTO. In order to participate, an Applicant must submit a copy of the Notice of Allowance issued by the USPTO for the related U.S. application, and pursuant to Rule #154/2015, the Applicant must also file a request using service code 277, and pay the requisite fee of R$1,775 (approximately US$420). While the PPH pilot program is an important step by the INPI in addressing the patent application backlog, the subject matter limitation to oil and gas technologies may result in future legal challenges before the Federal Courts.

Will there be any improvement in the backlog anytime soon?

Given the current political and economic crisis in Brazil, it is unlikely that applicants will see an improvement in the backlog any time soon. Moreover, the Ministry of Health will likely support launches at risk in order to have copies of lower cost drugs available in the Brazilian market. While not the best news for applicants, the worst case scenario is that pending applications will remain in the same place in INPI’s queue.

Please continue to watch the BRIC Wall Blog for updates on patent examination in Brazil.

This post was written by Lisa Mueller and Caitlin Mac Nair of Michael Best and Roberto Rodrigues of Licks Attorneys.

The BRIC Wall Blog is pleased to present the following guest post by Ivan Burkov, Ph.D.

This post will examine recent patent litigation between Genentech (a U.S. subsidiary of Hoffmann-La Roche Ltd. (Roche)) and the Russian company, Biocad JSC (Biocad). Because of the significance of this litigation for the biopharmaceutical industry in Russia, a detailed analysis of the litigation and its implications is provided below.

MabThera® and Biocad’s biosimilar version

In 2006, Roche/Genentech (Roche) launched MabThera® (rituximab) in Russia. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is found primarily on the surface of B-cells. Rituximab destroys B cells and is used to treat diseases characterized by excessive numbers of B cells, overactive B cells or dysfunctional B cells. Examples of such diseases include non-Hodgkin’s lymphoma, leukemia and autoimmune disorders. As a result, rituximab is on the World Health Organization’s List of Essential Medicines. In 2014, worldwide sales of rituximab exceeded $7 billion U.S. dollars.

Rituximab was initially developed by Biogen Idec and is protected by patents throughout the world. A Russian patent, RU 2139731 (the ‘731 patent), entitled “Method of treatment, antibodies, hybridoma”, claims the use of rituximab in treating lymphomas. The ‘731 patent expired in 2013. An Eurasian patent, EA 004107 (the ‘107 patent), entitled “Combinational therapy of B-cell lymphomas with the use of anti-CD20 antibodies”, also claims the use of rituximab to treat lymphomas. The ‘107 patent expires on November 8, 2019. Both the ‘731 and ‘107 patents claim methods of medical treatment which are excluded from patentability in many countries. However, such claims are permitted in the Russian and Eurasian patent systems.

Following the development of the Russian biotechnology industry in late 2000’s, several local biopharmaceutical companies began producing biologics and biosimilars. One such company, Biocad (www.biocad.ru), described itself as a “full cycle Russian biopharmaceutical company, holding the leading position for investment attractiveness among leading pharmaceutical companies”.

Not surprisingly, in 2012, at the beginning of the patent-cliff era, many local Russian companies directed their focus towards developing biosimilar versions of “blockbuster” biologics (such as, for example, Embrel®, Neulasta®, etc.). From the Russian authorities’ point of view, rituximab was one of the key targets for import substitution due to the fact that it was included in the essential drugs list and the Federal “7 Nosology” program (which is the Russian federal reimbursement program which pays for the treatment of many high costs diseases). However at the time, Roche was the only supplier of rituximab in Russia. As a result, in 2013, state-procurement of rituximab accounted for about $217 million (U.S.) dollars of the Russian federal budget.

In 2014, despite encountering administrative hurdles during state registration, Biocad launched a rituximab biosimilar called “AcellBia”, for the treatment of blood cancers. At that time, the ‘731 patent was expired. Shortly thereafter, Biocad received a $240 million (U.S.) dollar state procurement contract for the supply of rituximab, essentially eliminating Roche from the marketplace.

Ensuing patent litigation

In 2015, Roche filed a lawsuit against Biocad alleging infringement of the ‘107 patent. The ‘107 patent contains three claims:

A method for treating an individual with B-cell lymphoma comprising administration of a synergistic therapeutic combination of at least one anti-CD20 antibody and at least one cytokine, wherein said method has a better therapeutic effect over other methods of therapeutic treatment carried out separately.

A method for treating an individual with B-cell lymphoma comprising administration of a synergistic combination of a therapeutically effective amount of the anti-CD20 antibody and at least one chemotherapeutic agent; wherein the method enables destruction of cells of B-cell lymphoma with a synergistic effect greater than that achieved using anti-CD20 antibody or chemotherapeutic agent alone.

A method for reducing the risk of relapse of B-cell disease in a patient receiving a bone marrow or tissue grafts of peripheral blood stem cells after myeloablative chemotherapy, comprising the step of administering the amount of anti-CD20 antibody to effectively reduce the number of disease-causing CD20 antigen-expressive cells and to reduce the risk of recurrence of said B-cell disease in a patient.

The product insert provided with AcellBia partially mirrored the rituximab product insert (the AcellBia product insert mirrored the rituximab product insert regarding use in blood cancers; use in rheumatoid arthritis was not recited since this use was covered by another patent in Russia). Specifically, both inserts described the use of an anti-CD20 antibody either alone or in combination with at least one cytokine or chemotherapeutic agent for use in treating blood cancers. As a result, Roche argued that Biocad infringed independent claims 1 and 2 of the ‘107 patent when it began selling its AcellBia biosimilar in Russia.

The trial court held that none of Biocad’s actions could be considered to be an infringement of the claims of the ‘107 patent. According to the court, the claims of the ‘107 patent provided legal protection for a method of treatment. The production and marketing of a medicine did not necessarily lead to the use of the medicine as a treatment. Because Biocad was not a medical organization and was not licensed to perform any medical activities, it could not offer or provide services for the use of the patented method of treatment. As a result, Roche was unable to prove infringement.

In addition, Biocad was able to prove that it had not induced infringement of the ‘107 patent. Specifically, Biocad argued that the independent claims of the ‘107 patent assumed the co-administration of rituximab with a cytokine or chemotherapeutic agent (such as INF-α, INF-γ, IL-2, GM-CSF, G-CSF, fludarabine, cyclophosphamide, doxorubicin, vincristine and prednisone), each of which was available by prescription only. Because Biocad did not produce any of these cytokine or chemotherapeutic agents, it argued that its production and marketing of AcellBia did not infringe the ‘107 patent in the absence of these agents which were required to achieve the claimed synergistic effect.

Based on these findings, the trial court rejected Roche’s claim of infringement. Roche did not appeal and voluntarily abandoned the ‘107 patent.

What does this decision mean to the Russian pharmaceutical industry?

The litigation between Roche and Biocad is the first patent infringement case in Russia involving method of treatment claims. As a result, the decision raises questions about whether method of treatment claims will be enforceable in the future. Certainly, this decision highlights that method of treatment claims are less reliable than claims claiming compositions of matter or methods of use.

Future implications?

After its victory against Roche, Biocad went public and challenged the unfavorable aspects of Russian intellectual property law, arguing that certain types of patents violate the principles of fair competition. Specifically, according to Biocad’s Legal and Administrative Affairs Director, Alexey Katkov:

…There are substantial patents when a company really protects its new products, and there are instruments for holding monopoly on the market. When a deadline is due for patent protection of a molecule, manufacturers start making continuing patent applications for methods of treatment, use, etc., thus, extending the patent life of the drug…

Among the numerous state bodies of the Russian Federation, the Federal Antimonopoly Service (FAS) took an interest in preventing the scenario mentioned by Mr. Katkov. Very quickly, FAS released an official communication in which it stated that it was considering the possibility of banning divisional patent applications. Specifically, FAS stated that the “artificial extension of the monopoly by certain pharmaceutical companies” prevented other fair competitors from entering the market, thereby delaying the emergence of affordable generics and biosimilars.

Additionally, according to the information published in Russian newspaper “Vedomosti” on March 1, 2016, the FAS has begun discussing amendments to Russian patent law which will allow Russian companies to use inventions claiming medicines and medical devices without the consent of the patent holder. If such amendments are passed, the end result would be the compulsory licensing of pharmaceutical patents in Russia (see, (http://www.thepharmaletter.com/article/russia-may-start-compulsory-licensing-of-foreign-drugs ))

Even though FAS has no legal power to “ban” divisional patent applications or implement compulsory licensing, the question is now being discussed by various stakeholders, including local businesses and ministries. While still too early to know the outcome, the overall political trend of such a discussion fits with strong government support of local industry players, most of which are still only able to produce generic medicines.

In the meantime, Biocad has announced that it is currently involved in three patent disputes and actively preparing for another four, all of which are expected to be initiated in the near future. Specifically, Biocad is looking to challenging patent claiming the use of rituximab in treating rheumatoid arthritis.

This post was edited by Lisa Mueller.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances. The opinions expressed herein are those of the author. Comments or questions on this article can be addressed to the author (vanyaburkov@gmail.com) or Lisa Mueller (llmueller@michaelbest.com).

The Israeli Patent Office (IL PTO) recently accepted the marketing authorization notification date from the European Medicines Agency (EMA) as the date to be used when calculating the duration of an Israeli patent term extension (PTE). This decision represents a change from previous practice in which the EMA marketing authorization grant date was used to calculate PTEs.

The Israeli PTE system is unique as it is based on a series of linkages to the expiration date and extension periods of an U.S. PTE and any Supplementary Protection Certificates (SPCs) granted in any of the European Union “five” (EU-5) countries (United Kingdom, Italy, France, Spain and Germany). Additionally, an Israeli PTE expires no later than 14 years from the earliest date in which a regulatory approval was obtained in the U.S. or in one of the EU-5 countries.

Prior to this change, a petition for a PTE was filed with the IL PTO for apixaban (Eliquis®). The Israeli Commissioner of Patents (Commissioner) held that the EMA marketing authorization grant date, not the EMA marketing authorization notification date, should be used to calculate the PTE. As a result, the PTE for Eliquis® would have expired in Israel two days earlier than it would have if the notification date were used to calculate the extension period. The Commissioner justified his decision by referring to the lack of uniformity between the different European Patent Offices on the issue of whether the EMA authorization grant or notification date should be used to calculate the duration of SPCs. The IL PTO reached the same conclusion when deciding the PTE petition for secukinumab (Cosentyx®), holding that an IL PTE period is calculated based on the EMA marketing authorization grant date. In this case, the PTE would have expired four days earlier than it would of if the notification date were used.

However, the IL PTO was required to reevaluate its position after the Court of Justice of the European Union (CJEU) published a binding decision in Seattle Genetics Inc. v Österreichisches Patentamt (case C-471/14) holding that the EMA marketing authorization notification date must be used to calculate the expiration period of SPCs. The patentee argued that the IL PTO was bound to follow the final decision of the CJEU holding that the EMA marketing authorization notification date should be used rather than the grant date. As a result, the IL PTO reevaluated its position and followed the CJEU ruling.

This post was written by Lisa Mueller and Rikki Hullinger of Michael Best and Liad Whatstein of Liad Whatstein & Co.